Labeling Engineer – Medical Device

CoreTek Labs

📍Minneapolis, MN
Posted May 20, 2026
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Job Overview

Position

Labeling Engineer – Medical Device

Company

CoreTek Labs

Location

Minneapolis, MN

Work Type

On-site

Job ID

li-4415667244

Job Description

🚀 Hiring: Labeling Engineer – Medical Device

📍 Minneapolis, MN

🕒 Long Term Contract

👨 💻 8+ Years Experience

Looking for experienced professionals with strong expertise in medical device labeling and regulatory compliance.

🔑 Key Skills:

• Medical Device Labeling (IFU, Packaging, eIFU)

• FDA 21 CFR Part 801 & 820

• EU MDR Compliance

• ISO 13485, ISO 20417, ISO 15223

• Labeling Risk Assessment & Documentation

• PLM Tools (Windchill, Agile, SAP)

• UDI Implementation

• Labeling Tools (Loftware, Bartender, P360)

• Adobe Illustrator, InDesign

• Project Management & Onsite Coordination

• Stakeholder Management & Customer Communication

• Change Management & Governance

• Cross-functional Collaboration (RA, QA, R&D, Ops)

✦

Interview Prep

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Key Skills

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Preferred:

Practice Questions

💡Technical Questions (3)
  • 1.How do you approach labeling risk assessment for a medical device, and which standards guide your process?
  • 2.Can you explain the key differences in labeling requirements between FDA 21 CFR Part 801 and the EU MDR, particularly regarding eIFUs and UDI?
  • 3.Walk me through your process for managing a labeling change request from initiation through implementation in a PLM system like Windchill.
🎯Behavioral Questions (3)
  • 1.Tell me about a time you had to align conflicting priorities from Regulatory Affairs and Operations regarding a labeling change.
  • 2.Describe a situation where you had to manage a significant labeling change under tight governance and strict timelines.
  • 3.Give an example of how you successfully implemented UDI across a complex product portfolio.
🧩Situational Questions (2)
  • 1.A critical defect is found in printed packaging labels right before a major production run, and R&D says the product cannot ship without it. How do you handle this?
  • 2.You are tasked with transitioning from paper IFUs to eIFUs for a product line distributed globally. What are your immediate first steps?

Resume Keywords

Make sure these keywords appear on your resume

EU MDR21 CFR Part 801IFUUDI ImplementationLabeling Risk AssessmentISO 15223WindchillLoftwareChange ManagementCross-functional CollaborationeIFUMedical Device Labeling

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